OMNI TENS

Stimulator, Nerve, Transcutaneous, For Pain Relief

OMNI INTL., INC.

The following data is part of a premarket notification filed by Omni Intl., Inc. with the FDA for Omni Tens.

Pre-market Notification Details

• Device ID: K821523
• 510k Number: K821523
• Device Name: OMNI TENS
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: OMNI INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1982-05-21
• Decision Date: 1982-06-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858703006108	K821523	000